FDA Adverse Event
Injury
Summary report: N
GEM DR
MDR report key: 3051532
·
Received April 10, 2013
Report
- Report Number
- 9614453-2013-00955
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- January 17, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LWS
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE 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 PRODUCTS: 4568 IMPLANTABLE PACING LEAD 2002 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PATIENT'S DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. THE PATIENT STATED THE ORIGINAL DEVICE WAS "DEFECTIVE" AND "ALARMS WERE GOING OFF". FOLLOW-UP WAS CONDUCTED TO OBTAIN INFORMATION ON THE PATIENT AND WHETHER THE EVENT WAS DEVICE RELATED, BUT THE ATTEMPTS WERE UNSUCCESSFUL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 149765 | GEM DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | IPG MFG SWITZERLAND | 7271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00057 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |