MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97713

Device Problems Unstable (1667); Charging Problem (2892); Communication or Transmission Problem (2896)

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

Event Date 03/07/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that the patient was having poor coupling and was not getting any black boxes when recharging.An x-ray was performed and it was determined that the ins was not flipped.The decision was made to replace the ins.During the replacement surgery, it was determined that the ins was flipped/in an upside-down position.It was noted that during the original implant surgery, the ins was implanted properly and the surgeon had asked for confirmation on how the ins was to be inserted.No patient symptoms were reported.No further complications are anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative.It was reported that the ins was implanted properly at the initial implant procedure.At explant, the surgeon was surprised that the ins was inverted/upside-down.The cause of the ins flip remains unknown.No further complications are anticipated.

Manufacturer Narrative

(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the ins (b)(4) found c200 ins functionally okay/insignificant anomalies.See product analysis summary below.Product analysis #701742429: analysis information -- 2017-05-12 13:54:52 cst pli# 10 product id# 97713 the implantable neurostimulator (ins) passed functional testing.The ins passed the final functional test on the automated test console.A lab functional test determined there was good stable output on the electrode pairs the ins had when it was received.A lab functional test determined there was good stable output on all electrode pairs.Analysis determined there were no issues when pressing on the ins can.The ins was recharged at room temperature with 1 cm spacing between the recharger antenna and the ins and no issue was observed.{} the ins was recharged at room temperature with 1 cm spacing between the recharger antenna and the ins and no coupling issues were observed.{} analysis determined the telemetry was acceptable.Due to the reported complaint, a coupling test was performed to verify the ins was obtaining good coupling.Recharging was performed at 0, 1, 2, and 3 cm spacing to monitor coupling.{tested the coupling between recharge antenna and ins at body temperature and various spacings.The results were 8 bars coupling at 0 cm spacing, 8 bars coupling at 1 cm spacing, 4 bars coupling at 2 cm spacing, and 0 bars coupling at 3 cm spacing.} the same coupling was observed on a known good ins.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6438758
• MDR Text Key: 70996157
• Report Number: 3004209178-2017-06468
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2017
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2016
• 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: 48 YR