KIT IMPLANTABLE SLIM TIP LEAD, 90CM
Report
- Report Number
- 1627487-2024-08584
- Event Type
- Injury
- Date Received
- May 9, 2024
- Date of Event
- April 18, 2024
- Report Date
- July 29, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- PMP
- UDI-DI
- 05415067027160
- PMA / PMN Number
- P150004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DATE OF EVENT IS ESTIMATED DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT INFORMATION AND PATIENT¿S WEIGHT. FURTHER INFORMATION WAS REQUESTED BUT NOT YET RECEIVED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: 90CM SLIMTIP IMPLANT LEAD KIT, ABT, MODEL: MN10450-90A, UDI: (B)(4), SERIAL:(B)(6) , BATCH: 6853892
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
IT WAS REPORTED THAT PATIENTS LEAD HAS HIGH IMPEDANCES. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE THE LEAD THAT ASSOCIATED WITH THE ISSUE.
ADDITIONAL INFORMATION INDICATES THAT FOLLOWING A FALL PATIENT EXPERIENCED INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN LEAD WAS EXPLANTED TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772579 | KIT IMPLANTABLE SLIM TIP LEAD, 90CM | DRG LEAD | PMP | ABBOTT MEDICAL | MN10450-90A | 6853892 | 05415067027160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other | DRG IPG| DRG LEAD |