FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2813288
·
Received October 31, 2012
Report
- Report Number
- 2183613-2012-01936
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- July 30, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- 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) LCD (LIQUID CRYSTAL DISPLAY) IS OUT OF SPECIFICATION (SEGMENTS MISSING). MAIN PRINTED CIRCUIT BOARD AND BATTERY RELEASE ARE CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED. BATTERY DRAWER, LEAD FLEX COVER, RING COVER, AND TWO SIDE BAIL COVERS ARE BROKEN. UPPER AND LOWER CASES ARE BROKEN AND CONTAMINATED. TWO SIDE BAILS ARE MISSING.
Description of Event or Problem · 1
IT WAS REPORTED THE CASE WAS BROKEN. 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 |