MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

Device Problems Break (1069); High impedance (1291); Unable to Obtain Readings (1516); Communication or Transmission Problem (2896); Connection Problem (2900)

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

Event Date 08/21/2014

Event Type  malfunction  

Event Description

It was reported that at a normal implantable neurostimulator (ins) battery replacement, when the implanted lead was connected to the new ins, high impedance greater than 4000 was found on all electrodes.There was also a ¿???¿ error message with impedances on all electrodes and a telemetry or interrogation issue.When the doctor tried to remove the lead from the ins to clean the lead and reconnect the devices, electrodes 2 and 3 fractured inside the header block of the new ins, deeming it unusable as it was unable to secure a connection because a lead could not be fed into the header block.The fractured lead was explanted and replaced by a new lead and a new ins was used.The product issue was resolved and the cause of the issue was not determined.There were no patient symptoms.The patient was doing great.

Manufacturer Narrative

Product id: 3889-28, lot# v280397, implanted: (b)(6) 2009, explanted: (b)(6) 2014, product type: lead.Product id: 3037, serial# (b)(4), product type: programmer.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
• 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: 4088705
• MDR Text Key: 4745585
• Report Number: 3007566237-2014-02575
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/15/2014
• 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: 00077 YR