MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN DEEP BRAIN STIMULATION LEAD; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number NEU_UNKNOWN_LEAD

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

It was reported that after the stimloc base plate was screwed into the patient¿s cranium that the slider ¿would not sit and click in the stimloc base plate.¿ the operating physician reportedly ¿tried repositioning the stimloc base plate, however the slider would still not sit in the base plate correctly.¿ a second stimloc was tried at that time and was noted to have ¿worked perfectly.¿ the base plate in question was retained at the time of report, however it was noted the slider had been mistakenly discarded.There was ¿no¿ reported patient injury and the patient was reported to have ¿recovered fully¿ following the incident.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id 924256, lot# 082205614a, product type: accessory; product id 924256, lot# 082205614a, product type: accessory.(b)(4), analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Manufacturer Narrative

Device evaluation: analysis of the stimloc base found ¿the base worked properly with a known good clip, cap, and lead; however, one of the two screw holes in the base was found to be deformed and molded incorrectly.The hole is smaller near the bottom and larger at the top.The diameter of the hole in both areas is out of specification.It measured 0.075" at the bottom and 0.092" at the top (spec: 0.068"±0.005").¿.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN DEEP BRAIN STIMULATION LEAD
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4024865
• MDR Text Key: 4876727
• Report Number: 3007566237-2014-02334
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_LEAD
• Device Catalogue Number: NEU_UNKNOWN_LEAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00072 YR