MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problems Material Separation (1562); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported the patient experienced pain and less than 50% therapy relief when their ¿original left side symptoms returned.¿ it was reported the event was due to an ¿insertion retention¿ issue involving an implanted lead anchor.It was stated the anchor¿s ¿titanium component disassociated from the silicone component¿ at the time of the event.A revision was required as a result of the event; whereby the lead was secured with sutures.The issue was reportedly resolved following the revision and the patient was alive with no injury at the time of report.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant product: product id 3550-39, lot # 0207250651, implanted: (b)(6) 2015, product type accessory.(b)(4).

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: 4735776
• MDR Text Key: 15321182
• Report Number: 3007566237-2015-01137
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/12/2015

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?: No
• Initial Date Manufacturer Received: 04/12/2015
• Initial Date FDA Received: 04/29/2015
• 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
• Patient Age: 00063 YR