FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2790654
·
Received October 15, 2012
Report
- Report Number
- 2183613-2012-01675
- Event Type
- Malfunction
- Date Received
- October 15, 2012
- Date of Event
- June 20, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Removal / Correction Number
- Z-0430-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) BATTERY DRAWER IS BROKEN. BATTERY CONTACTS AND BATTERY FLEX ARE CORRODED. BATTERY RELEASE IS CONTAMINATED. UPPER AND LOWER CASES ARE CRACKED (BROKEN). SIDE BAIL COVERS, RING COVER, SIDE BAILS, AND RING ARE MISSING.
Description of Event or Problem · 1
IT WAS REPORTED THE CASE IS CRACKED AND THE HANDLE IS MISSING. THE EXTERNAL PULSE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR REPAIR AND CALIBRATION, ANALYZED AND TESTED OUT OF SPECIFICATION. NO INFORMATION WAS RECEIVED INDICATING PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |