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

Model Number NEU_UNKNOWN_LEAD

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Type  Injury  

Event Description

It was reported the parksinons¿ disease patient¿s stimloc device ¿caused a cerebral spinal fluid (csf) leak.¿ the operating physician indicated ¿the location was between the chassis and skull and he used a biological protein gel to fill the gap during the surgery.¿ the patient was noted to be ¿good after the surgery¿ with the stimloc remaining implanted.It was reported the stimloc has been had been inspected prior to use and there were no abnormalities found; however there was a package abnormality noted before opening.No further information was available regarding the event; additional information has been requested.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id neu_stimloc_acc, serial# unknown, product type: accessory.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was confirmed that there were not any package abnormalities before opening the device before use.

• Brand Name: UNKNOWN LEAD
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4795368
• MDR Text Key: 5858836
• Report Number: 3007566237-2015-01424
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2015
• 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 Outcome(s): Required Intervention