FDA Adverse Event
Injury
Summary report: N
MAXIMO VR
MDR report key: 2123077
·
Received June 14, 2011
Report
- Report Number
- 6000144-2011-02254
- Event Type
- Injury
- Date Received
- June 14, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S37
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS. THE RIGHT VENTRICULAR LEAD EXPERIENCED OVERSENSING. THE LEAD WAS CAPPED AND NOT REPLACED AT THE PATIENT'S REQUEST. IT WAS FURTHER REPORTED THAT THE SUPERIOR VENA CAVA (SVC) COIL OF THE LEAD HAD PREVIOUSLY BEEN CAPPED DUE TO FRACTURE. IT WAS ALSO FURTHER REPORTED THAT THE PATIENT STATED THE DEVICE "FAILED" AND THAT HE "WAS SHOCKED AND DID NOT NEED IT". NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMO VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7232CX | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Hospitalization| L| R |