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

Model Number 97713

Device Problems High impedance (1291); Low Battery (2584); Device Displays Incorrect Message (2591)

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

Event Date 12/06/2016

Event Type  malfunction  

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 who was implanted with a neurostimulator.It was reported that there were high intra-operative impedances on contacts 8-15.The health care professional (hcp) removed and wiped down the contacts.Reinserting the lead multiple times did not resolve the issue.The lead was then tested with the multi-lead trialing cable (mltc) and impedances were fine.The manufacturer representative was going to try another implantable neurostimulator (ins).The event occurred on (b)(6) 2016.Patient and device information was not available at the time of the call.Additional information was provided later the same day from the manufacturer representative reporting that the implantable neurostimulator (ins) was changed out for end of service (eos).At pre-operation the manufacturer representative was able to read the battery and ascertain that all impedances were within normal limits.Intra-operatively channels 8-15 were out of range.The leads were taken out several times to make sure that they were clean, dry, correctly placed, and that the header was dry.No changes were noted.The 2 leads were put in a multi-lead trialing cable (mltc) and all impedances came back normal.A new battery was used after the original troubleshooting call with technical services.All impedances were within normal limits using the new battery.The old battery with the impedance issue was never implanted and would be returned for analysis.Device and health care professional (hcp) information was provided but the patient information was not yet provided at this time.It was reported that the patient was alive with no 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

Additional information from the representative provided the patient information and stated that the ins would be returned by ups tomorrow.

Manufacturer Narrative

Supplemental to update codes, (b)(4) no longer apply.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the device will be returned for analysis the device was replaced.It was noted that there was no patient injury and the patient recovered without sequela after the device was removed.

Manufacturer Narrative

Analysis of the ins (b)(4) found no anomalies.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.

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.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6152982
• MDR Text Key: 61734695
• Report Number: 3004209178-2016-25380
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/14/2017

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
• Device Expiration Date: 04/28/2017
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/07/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 02/13/2017; 02/13/2017; 02/13/2017; 02/13/2017; 02/13/2017
• Supplement Dates FDA Received: 12/07/2016; 12/08/2016; 12/27/2016; 02/14/2017; 09/27/2017; 09/27/2017; 09/27/2017; 09/28/2017; 09/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• 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 Age: 66 YR