MAUDE Adverse Event Report: MPRI SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number	977C265
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Scar Tissue (2060); Therapeutic Effects, Unexpected (2099)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that in 2019, while the lead was connected to a competitor ins, the patient started experiencing inadequate back and buttock pain relief.The patient saw their physician, and on (b)(6) 2020, the lead was removed.During the removal of the lead, it was found that scar tissue was adhered to each of the contacts on the lead.The lead was successfully removed and was sent to the hospital pathology department, and would be returned to the manufacturer after pathology was done with it.During the lead explant, another lead was placed and attached to extensions, which were externalized and connected to a wireless external neurostimulator (wens).No further complications were reported or anticipated.
Event or Problem Description
Additional information was received from a manufacturer¿s representative (rep).The rep reported that the patient came from another district with another manufacturer¿s ins already implanted.The rep was unaware of when exactly the patient had surgery.The rep reported that the patient¿s 2x8 lead was removed and a buried 565 paddle trial was successfully done.A new ins was implanted one week after the 565 was implanted/trialed.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 10235456
• Report Number: 2649622-2020-12825
• Device Sequence Number: 3093087
• Product Code: GZB
• UDI-Device Identifier: 00643169464650
• UDI-Public: 00643169464650
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2021
• Device Model Number: 977C265
• Device Catalogue Number: 977C265
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 159