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

Model Number NEU_INS_STIMULATOR

Device Problems Break (1069); High impedance (1291)

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

Event Date 04/28/2015

Event Type  Injury  

Event Description

It was reported that impedances of ¿>40000¿ ohms were measured on electrodes 0 and 1 following the connection of the deep brain stimulation (dbs) system.The connections and setscrews of the lead, extension, and implantable neurostimulator (ins) were all reconnected and retightened; however, there was no change in the impedance issue.The patient¿s extension was then replaced and ¿normal¿ impedances were then measured in all electrode combinations.The extension was reportedly replaced due to a ¿breakage.¿ there was no patient injury or death due to the event and the patient ¿recovered without sequela.¿ additional information has been requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), explanted: (b)(6) 2015, product type: extension.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 3708660, serial# (b)(4), explanted: (b)(6) 2015, product type: extension.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 extension found that ¿conductors #0 and #1 were broken 2.8 cm from the proximal end.¿.

Manufacturer Narrative

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

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• 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: 4781148
• MDR Text Key: 16853966
• Report Number: 3007566237-2015-01352
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 05/19/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 06/26/2015
• Supplement Dates FDA Received: 05/26/2015; 06/01/2015; 06/29/2015; 09/18/2017
• 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 Outcome(s): Required Intervention