MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2004-09-08 for SYNERGY 7427 NA manufactured by Medtronic Puerto Rico Operations Co Medrei.
[36948713]
Patient Sequence No: 1, Text Type: N, H10
[36948714]
Paramedic reported patient was shocked while going through security gast at "(b)(6) " store. Paramedic attempted to turn off patient's stimulator with synergy ez patient programmer. After the device was off, the patient was assisted outside. Manufacturer recommended the patient follow up with hcp, leaving the device off until then. Patient was implanted 1 week prior to event. No report of device explanation. A follow up report will be sent when additional information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2004-01161 |
| MDR Report Key | 5305668 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2004-09-08 |
| Date of Report | 2004-08-27 |
| Date Mfgr Received | 2004-08-27 |
| Device Manufacturer Date | 2004-04-28 |
| Date Added to Maude | 2015-12-17 |
| 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 | PARAMEDIC |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BARBARA PAHL |
| Manufacturer Street | 710 MEDTRONIC PKWY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050856 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS CO MEDREL |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYNERGY |
| Product Code | IPG |
| Date Received | 2004-09-08 |
| Model Number | 7427 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2005-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO MEDREI |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-09-08 |