FDA Adverse Event
Malfunction
Summary report: N
SENSIA DR
MDR report key: 2608178
·
Received June 11, 2012
Report
- Report Number
- 6000144-2012-03209
- Event Type
- Malfunction
- Date Received
- June 11, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- Z-2120-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT COMPLAINED ABOUT FEELING MUSCLES SPASMING AROUND THE DEVICE AFTER THROWING AN OBJECT. FOLLOW UP WAS ATTEMPTED FOR ADDITIONAL INFORMATION, BUT WAS UNSUCCESSFUL. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SENSIA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | SEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other | 5076 X2 IMPLANTABLE PACING LEADS |