MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-06 for PREVAIL S 8086B manufactured by Medtronic, Inc..
[72176143]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[72176144]
It was reported that the patient fell within the past couple of weeks and feeling" terrible". Patient stated feeling the implantable pulse generator (ipg) pacing and stated feeling weak. During system follow up check, when the patient rate was dropped to 40, patient felt nauseated and dizzy. The patient continued to have intrinsic beats even when paced at 40. It was also reported that pacing problem exhibited, as not consistently capturing, unable to perform threshold test, not sensing properly despite programming to lowest setting, and not sensing intrinsic beats. Diagnostic testing/troubleshooting performed. The ipg and right ventricular (rv) lead remain in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[77803091]
Patient Sequence No: 1, Text Type: N, H10
[77803092]
Follow up information received indicated reprogramming was performed via adjusted sensitivity. The ipg and implantable pacing lead (ipl) remain in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[99564925]
Corrected information: sex, and date of birth. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182208-2017-00385 |
| MDR Report Key | 6465658 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-06 |
| Date of Report | 2017-01-04 |
| Date of Event | 2017-01-04 |
| Date Mfgr Received | 2017-04-28 |
| Date Added to Maude | 2017-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREVAIL S |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE |
| Product Code | LWO |
| Date Received | 2017-04-06 |
| Model Number | 8086B |
| Catalog Number | 8086B |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-04-06 |