FDA Adverse Event
Injury
Summary report: N
ENRHYTHM
MDR report key: 3280083
·
Received August 10, 2013
Report
- Report Number
- 3004209178-2013-13866
- Event Type
- Injury
- Date Received
- August 10, 2013
- Report Date
- May 4, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Removal / Correction Number
- Z-1440-2010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND REVEALED NORMAL BATTERY DEPLETION.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT THERAPY: 4092-58 IMPLANTABLE PACING LEAD, IMPLANT DATE: (B)(6) 2006-06. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET DISCOMFORT FROM THE DEVICE IMPLANTED SUBPECTORAL. THE DEVICE WAS EXPLANTED AND REPLACED SUBCUTANEOUSLY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 384248 | ENRHYTHM | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | P1501DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR | Hospitalization| R | 4592-53 IMPLANTABLE PACING LEAD |