MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for SPRINT 6945-65 manufactured by Mpri.
[185709224]
Concomitant medical products: 419478 lead, implanted: (b)(6) 2005. Dtba1d1 crt-d, implanted: (b)(6) 2014. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185709225]
It was reported that the right ventricular (rv) lead exhibited unexplained counts to the sensing integrity counter (sic) as well as suspected oversensing of atrial fibrillation (af). Additionally there have been high rate non-sustained tachycardia. The rv lead remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188941002]
Product analysis summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed. Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2649622-2020-06677 |
| MDR Report Key | 9903170 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2001-02-20 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPRINT |
| Generic Name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER |
| Product Code | LWS |
| Date Received | 2020-03-31 |
| Model Number | 6945-65 |
| Catalog Number | 6945-65 |
| Device Expiration Date | 2003-02-20 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5076 | 2020-03-31 |